Identity
- Trade Name
- TEMPLATE 8.00MM/8.75MM FDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, single-use FDA UDI
- Model / Reference
- 16972 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810012485579 FDA UDI
- 510(k) Number
- K041595 FDA UDI
- FDA Product Code
- HWT FDA UDI
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Orthopaedic prosthesis implantation positioning instrument, single-use
Template 8.00mm/8.75mm by Biopro, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic prosthesis implantation positioning instrument, single-use.
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Cleared under the same submission
K041595 also covers:
- 5-Star Template — BIOPRO, INC.
- CHISEL — BIOPRO, INC.
- FIRST MPJ HEMI COMPLETE KIT — BIOPRO, INC.
- First MPJ Instrument Tray — BIOPRO, INC.
- Impactor Tip LG — BIOPRO, INC.
- LESSER MPJ TRIAL 10.25MM — BIOPRO, INC.
- LESSER MPJ TRIAL 11.0MM — BIOPRO, INC.
- LESSER MPJ TRIAL 14.00MM — BIOPRO, INC.
- MPJ TRIAL 17mm (SM) — BIOPRO, INC.
- MPJ TRIAL 20mm (MD) — BIOPRO, INC.
- MPJ TRIAL 21.5mm (ML) — BIOPRO, INC.
- MPJ Trial 21.5mm (ML) — BIOPRO, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Biopro, Inc.
Sources (1)
- FDA UDI e1b8eb5b-a429-4c6e-a4bf-40b32b6d67cb 33 fields · synced Jun 1, 2026